Atlas FDA

Stryker Neptune 3 Waste Management System

FDA 510(k) clearance K153407 · decided 2016-04-25

Clearance details

K-number
K153407
Device name
Stryker Neptune 3 Waste Management System
Applicant
Stryker Corporation
Decision
Substantially Equivalent
Date received
2015-11-25
Decision date
2016-04-25
Days to decision
152 days
Clearance type
Traditional
Product code
JCX
Device class
2
Regulation number
878.4780
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Kalamazoo, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
120 V Neptune 3 Rover, Model Number: 0703-001-000 recall (Z-2630-2016)Stryker Instruments Div. of Stryker Corporation2016-08-23

PMA approvals by this applicant

RecordFirmDate
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S005)Stryker Corporation2016-08-09
SBI BRAUN-CUTTER TRAPEZ-METACARPAL PROSTHESIS (P960053/S004)Stryker Corporation2007-09-28
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053/S003)Stryker Corporation2002-12-31
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S002)Stryker Corporation1998-06-04
TOTAL TRAPEZIO METACARPAL PROSTHESIS (P960053/S001)Stryker Corporation1998-06-04
BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS (P960053)Stryker Corporation1997-06-19